# DTS: Sucker, Cardiotomy Return, Cardiopulmonary Bypass

- Device class: 2; regulation: 21 CFR 870.4420; FDA's rule: 510(k) exempt
- FDA decisions: 9
- Recalls: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1979: 1
- 1980: 2
- 1989: 1
- 1990: 1
- 1991: 1
- 1997: 1
- 1998: 1
- 2006: 1

## Most-cited predicates
- K963756: Ibc Cardiac Suction Ward (1997), cited by 1
- K982891: California Medical Laboratories Inc. Standard and Small Rigid Tip Suction Wands (1998), cited by 1

Source page: https://510kreport.com/product-code/DTS
Data by year (CSV): https://510kreport.com/product-code/DTS.csv